FDA Adverse Event
Injury
Summary report: N
FETAL MONITOR
MDR report key: 2098537
·
Received May 16, 2011
Report
- Report Number
- 9610816-2011-00256
- Event Type
- Injury
- Date Received
- May 16, 2011
- Report Date
- April 27, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- HFM
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT A PATIENT EXPERIENCED AN HYPOXIC-ISCHAEMIC EVENT DURING THE INTRA-PARTUM PERIOD AND RESUSCITATION INCIDENT INVOLVING A PHILIPS FETAL MONITOR. THERE IS AN ALLEGATION OF PERMANENT CENTRAL NERVOUS SYSTEM (CNS) INJURY TO THE CHILD, BUT THERE IS NO ALLEGATION OF ANY ROLE OF THE MONITOR IN CAUSING OR CONTRIBUTING TO THE EVENT OR OUTCOME. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PATIENT EXPERIENCED AN HYPOXIC-ISCHAEMIC EVENT DURING THE INTRA-PARTUM PERIOD AND RESUSCITATION INCIDENT INVOLVING A PHILIPS FETAL MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FETAL MONITOR | HFM | PHILIPS MEDICAL SYSTEMS | M1351A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |